Actively Recruiting
A Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Immunogenicity, and Initial Efficacy of EVM16 Injection Alone and Combined with Tislelizumab in Advanced or Recurrent Solid Tumors
Led by Peking University · Updated on 2025-03-18
78
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
P
Peking University
Lead Sponsor
S
Shanghai Cancer Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects and safety of a tumor vaccine called EVM16 alone and in combination with an anti-PD-1 antibody named tislelizumab. This trial focuses on patients with advanced or recurrent solid tumors who have not responded to standard treatments. The main goals are to assess the safety of EVM16, find the suitable dose, and evaluate how EVM16 works with tislelizumab. Participants will receive different dose levels of EVM16 either by itself or combined with tislelizumab, including dose escalation levels 1 through 3 and a dose expansion phase with the recommended phase 2 dose (RP2D). The study is non-randomized and open-label, meaning all participants know which treatment they receive. Treatments are given over a period of up to about one year. During the study, participants will be monitored for safety and side effects from the first dose until 90 days after the last dose. Researchers will also assess immune responses to EVM16 and measure how well the combination with tislelizumab controls the tumor. Follow-up includes tracking response rates, disease control, remission duration, and progression-free survival. Participants will undergo regular evaluations including tumor assessments and safety checks throughout the trial.
CONDITIONS
Brief Title
EVM16 Injection As a Single and Combination with Tislelizumab in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed recurrent or metastatic solid tumors not treatable by surgery or local therapy
- Advanced or recurrent solid tumors with prior standard therapy failure
- Expected survival longer than 6 weeks at consent
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 1
- Willingness to provide archival or fresh tumor tissue samples for EVM16 production
- Adequate treatment washout period before first study dose
- At least one measurable lesion per RECIST version 1.1 before enrollment
You will not qualify if you...
- Symptomatic, untreated, or curatively treated primary central nervous system malignancies or CNS metastases
- Uncontrolled co-morbid conditions
- Stroke or transient ischemic attack within 4 months before consent
- Male QTcF interval over 450 ms or female QTcF interval over 470 ms during screening
- Left ventricular ejection fraction less than 50% during screening
- Immunodeficiency or history/risk of autoimmune disease requiring systemic steroid or immunosuppressive drugs
- History of HIV or AIDS
- Co-infection with hepatitis B and C viruses
- Active infection requiring systemic therapy
- Concurrent use of other investigational cancer treatments at screening
- Previous treatment with cell therapy, tumor vaccines, cytokines, or growth factors for cancer control
- Prior intolerance to tislelizumab leading to permanent discontinuation
- Significant lung disease history or presence
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year
Participants receive EVM16 injection alone or combined with Tislelizumab to evaluate safety, tolerability, and efficacy in advanced or recurrent solid tumors.
Repeated visits for study drug administration and assessments during treatment
Duration - 90 days after last study dose
Participants are monitored for safety and tolerability for 90 days after the last study intervention.
Approximately 3 follow-up visits
Trial Site Locations
Total: 2 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200135
Actively Recruiting
Research Team
L
Lin Shen, MD
Y
Yanshuo Cao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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